Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01406405
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2011-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
Sponsor:
Justin Parker Neurological Institute
Organization:
Study Overview
Official Title:
Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEEK
Brief Summary:
Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.
Detailed Description:
Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2 weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: